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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06368908
Other study ID # 6I/2023/3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 8, 2023
Est. completion date December 30, 2024

Study information

Verified date April 2024
Source General and Teaching Hospital Celje
Contact Matej Podbregar, MD PhD
Phone +3864021560
Email matej.podbregar@guest.arnes.si
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ICU-Acquired weakness (ICU-AW) is a significant complication of critical illness. ICU-AW is common in patients with sepsis, systemic inflammatory response, and mechanically ventilated. It is estimated that around 50% of patients recovering from the primary illness remain in intensive care with characteristic muscle weakness. This leads to dependence on mechanical ventilation, prolonging costly intensive care hospitalization. The myopathy causes persistent functional impairment, endangering patients long after hospital discharge. Magnetic stimulation prevents inactivation atrophy of skeletal muscles, as demonstrated in the mobilized limb of rats. Transcutaneous magnetic stimulation of the quadriceps via the femoral nerve is a safe and painless method even when applied to humans. In patients with chronic obstructive pulmonary disease (COPD), quadriceps magnetic stimulation increased spontaneous contraction force compared to the control group and improved quality of life. Patients with COPD tolerate quadriceps magnetic stimulation well, as it does not affect oxidative stress in muscles but does increase the size of slow-twitch muscle fibers. In intensive care medicine, magnetic stimulation has been primarily used for diagnostic purposes in assessing diaphragm function, peripheral muscle strength assessment, and transcranial electrical stimulation as a diagnostic tool and therapeutic stimulation of brain cells. With the development of modern transcutaneous magnetic stimulators, the possibility arises for their use in intensive care medicine for therapeutic purposes such as preventing critical illness myopathy. To date, no research has been conducted on the use and effectiveness of magnetic stimulation of peripheral muscles in critically ill individuals. The aim of the study is to investigate the effect of Functional Muscle Magnetic Stimulation (FMS) on the development of ICU-AW.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcutaneous Functional Magnetic Muscle Stimulation
Peripheral neuromuscular system stimulation will be conducted for the quadriceps femoris muscle using a magnetic stimulator (Tesla stym, Iskra Medical, Otoce, SLO). For magnetic stimulation, we will use pulse trains (20-50 Hz) with intensities ranging from 0.5 to 2.5 Tesla. The stimulation trains will be up to 3-6 seconds long, and the duty cycle will be varied from 1:1 to 1:10. Muscles will be stimulated with a magnetic field intensity that triggers visible contraction. The stimulation will last for 55 minutes per selected limb and will be performed 5 days a week.

Locations

Country Name City State
Slovenia General Hospital Celje Celje

Sponsors (1)

Lead Sponsor Collaborator
General and Teaching Hospital Celje

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of Thickness of Thigh Muscles Measurement of Thickness of Thigh Muscles by Ultrasound
Thickness and cross-section of the muscle, muscle structure, assessment of subcutaneous edema will be evaluated using ultrasound examination with a linear probe 8-12MHz (UZ apparatus Vivid 70, GE Health care, USA). Ultrasound apparatus settings (frequency 12 Hz, Gain: 55 dB, Dynamic range: 75) will be kept constant for all patients, with depth adjusted only in the case of larger muscles. Measurements will be performed in transverse and sagittal muscle sections without and with compression of the ultrasound probe.
0 day, 3-5 days, 9-12 days
Secondary Measurement of Thigh Circumference On the thighs, we will mark transverse and longitudinal measurement points located at the lower 1/3 of the distance between the spino-iliac point and the midpoint of the patella. The circumference of the thigh on both legs will be measured three times (first: upon enrollment in the study; second: between days 3-5 after enrollment; and third: between days 9-12 after enrollment). 0 day, 3-5 days, 9-12 days
Secondary Assessment of Muscle Strength and Communication Ability If the patient is capable of meaningful communication (Ramsay sedation scale: 2 or 3 points), the muscle strength of the upper and lower limbs will be recorded using the recommendation and scale of the Medical Research Council of Great Britain (MRC).
On MRC scale sum of less than 48 points out of a maximum of 60 points or an average score of less than 12 ponts in 4 defined parts of the body are criteria for ICU-AW. MRC scale value of left and right leg will be compare. Lower MRC value is related to less muscle strength.
at admission and at the end of study (9-12day)
Secondary Body composition measurement by bioimpedance- Extracellular water Body composition of the right and left body part will be assessed by bioimpedance (Bodystat, USA). Extracellular water (%, litres) will be compared between left and right body part. 0 day, 3-5 days, 9-12 days
Secondary Body composition measurement by bioimpedance- Intracellular water Body composition of the right and left body part will be assessed by bioimpedance (Bodystat, USA). Intracellular water (%, litres) will be compared between left and right body part. 0 day, 3-5 days, 9-12 days
Secondary Body composition measurement by bioimpedance- skeletal muscle mass Body composition of the right and left body part will be assessed by bioimpedance (Bodystat, USA). Skeletal muscle mass (kg) will be compared between left and right body part. 0 day, 3-5 days, 9-12 days
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